On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary extension (2026 Extension) of its pandemic-era telehealth flexibilities, which are now scheduled to end on December 31, 2026. The DEA explained that another extension
Accountable Care Organizations
Medicare Telehealth Flexibilities Extended through September 30, 2025
By Conor Duffy, Danielle Tangorre, Michael Lisitano & Guest Contributor on
Posted in Academic Medical Centers, Accountable Care Organizations, COVID-19, Government Enforcement, Health Information Technology, Health Policy, Hospitals and Health Systems, Legislation, Licensure, Physicians and Allied Health Professionals, Privacy and Security, Reimbursement, Telehealth, Telemedicine
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team and Paul Palma, law intern at Robinson+Cole. Paul is not admitted to practice law.
On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare…
DEA Extends Telehealth Lifeline for Patients
By Conor Duffy & Guest Contributor on
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension of current COVID-era tele-prescribing flexibilities for another year – through December 31, 2025 – via…
HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care
By Conor Duffy & Yelena Greenberg on
Posted in Academic Medical Centers, Accountable Care Organizations, Department of Justice, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Policy, HIPAA, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Privacy and Security
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42…
DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024
On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of action” with respect to the prescribing of controlled substances via telemedicine. DEA is issuing a limited extension in order to give itself more time to finalize new standards governing tele-prescribing of controlled substances.Continue Reading DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024
Pending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities
By Leslie Levinson, Guest Contributor & Robinson+Cole's Health Law Group on
The Illinois House of Representatives recently voted in favor of passing HB 2222 (“the Bill”), which, if enacted, would amend the Illinois Antitrust Act to add new reporting requirements for certain transactions, including mergers, acquisitions, and contracting affiliations. These heightened requirements would impact healthcare facilities and provider organizations starting on January 1, 2024. The Bill is currently under consideration in the Illinois Senate and would need to be passed by the Illinois Senate and then signed by Illinois Governor J.B. Pritzker in order to be enacted into law.Continue Reading Pending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities
CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
By Conor Duffy, Guest Contributor & Robinson+Cole's Health Law Group on
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.
Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
Key Changes to the Medicare Shared Savings Program
By Robinson+Cole's Health Law Group on
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued changes to the Medicare Shared Savings Program to advance CMS’ broader strategy of growth, alignment, and equity. To improve the overall operations of the Shared Savings Program, CMS is finalizing changes that, among other things, will impact payment and Accountable Care Organization (ACO) beneficiary assignment, update quality reporting and performance requirements, and reduce the administrative burden for ACOs.Continue Reading Key Changes to the Medicare Shared Savings Program
CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule
By Robinson+Cole's Health Law Group on
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule (PFS). These final rules implement various updates and policy changes for Medicare payments under the PFS and OPPS, and made significant updates to the Medicare Shared Savings Program (MSSP), which go into effect on or after January 1, 2023. We summarize the key changes below and will elaborate on these rules in future posts.Continue Reading CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule
CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
By Conor Duffy, Michael Lisitano & Robinson+Cole's Health Law Group on
Posted in Academic Medical Centers, Accountable Care Organizations, Ambulatory Surgical Centers (ASC), Americans With Disabilities, COVID-19, Home Health Agencies, Hospice, Hospitals and Health Systems, Long Term Care and Nursing Homes, Medicare and Medicaid, Physicians and Allied Health Professionals
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.
Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:
Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers